Syringe devices

ABSTRACT

Described herein are syringe devices comprising a syringe including a therapeutic dose of at least one drug and a stopper. The syringe is housed and/or placed in an encasement. The plunger assembly can include a plunger, an actuator, and a spacer, wherein the plunger assembly is configured to move the stopper a predetermined distance without a user touching the plunger. Methods of assembling and using the syringe devices are also described.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a national phase entry of PCT/US2016/022956, filedMar. 17, 2016, which claims the benefit of U.S. provisional patentapplication No. 62/209,272, filed Aug. 24, 2015, and U.S. provisionalpatent application No. 62/235,984, filed Oct. 1, 2015, the entiredisclosure each of which is incorporated herein by reference.

FIELD

The present invention relates generally to syringes, encasements forsyringes, devices including syringes, and methods of using same.

SUMMARY

Described herein generally are syringe devices that can deliver atherapeutic dose of a drug. In some embodiments, the therapeutic dosecan be less than the amount of drug in the syringe. The devices can alsoprevent device tampering by a user and/or multiple uses of the samesyringe device. In some embodiments, the syringe devices describedherein can be used in an emergency or for delivery of an emergencyand/or time sensitive drug. The syringe devices can include a syringethat includes a dose of at least one drug and can deliver a therapeuticdose of the drug that can be less than the amount of drug in thesyringe. The syringe can also include a stopper and a gas bubble betweenthe at least one drug and the stopper. In other embodiments, a gasbubble is not needed and/or wanted.

The syringe devices can include an encasement to house the syringe andplunger assembly including a plunger rod, an actuator, and a spacer. Insome embodiments, when assembled, the syringe devices can prevent usersfrom tampering with the encased syringe and/or using it for more thanone drug delivery. In some embodiments, the syringe devices can besingle use and lock after use.

In various embodiments, the actuator and the spacer can be configured tobe secured around the plunger rod. The actuator can include channels andthe plunger rod can include protrusions, and the protrusions can beconfigured to fit within the channels and can provide an adjustableplunger rod location without moving a force application surface.

In some embodiments, the actuator itself can include a finger depressionlocation at the syringe device's force application location instead offorce being applied to the plunger rod as in conventional syringes.

The plunger assembly, in some embodiments, can be configured to move thestopper a predetermined distance without a user touching the plunger rodor being able to retract the plunger rod.

In some embodiments, the encasement can be a rigid plastic casing andcan include a window configured to allow a user to view the at least onedrug in the syringe to determine if the at least one drug has or has notexpired. A user can tell from potential cloudiness if the at least onedrug has expired.

In embodiments, the encasement can include a needle guard configured toallow the user to cover the needle after use. In such embodiments, theneedle guard can slide down from the encasement over the exposed needleto protect from accidental needle sticks after use.

The at least one drug can be any drug or combination of drugs describedherein. However, in some embodiments, the drug(s) can be a drug thatmight be used in an emergency situation. Such drugs can include, but arenot limited to epinephrine and glucagon. In some embodiments, atherapeutic amount of these drugs can be about 0.3 mg or about 0.15 mg.

Embodiments include syringe devices including a syringe comprising avolume of at least one drug and a stopper; a plunger assembly includinga plunger rod, an actuator, and a spacer. These syringe devices' plungerassemblies can be configured to provide substantially identical doses ofthe at least one drug even if more or less drug is provided in thesyringe by moving the stopper a predetermined distance. The volume ofthe drug in the syringe can be about 0.8 cc in some embodiments and thedose of drug delivered can be about 0.3 mg or about 0.15 mg.

Also described herein are methods using the herein-described syringedevices to deliver a drug(s). Some methods can be for administering atherapeutic dose of at least one drug. In some embodiments, theadministering can be in an emergency. The methods can include advancinga stopper through a syringe including the therapeutic dose of the atleast one drug.

This advancing can be a predetermined distance. In some embodiments, thestopper can only be advanced a predetermined distance by a plungerassembly including a plunger rod, an actuator, and a spacer. In otherembodiments, the plunger assembly can be configured to move the stopperwithout a user touching the plunger rod, but rather applying force tothe actuator.

In various embodiments, advancing the stopper the predetermined distanceallows a particular amount of drug to be extruded and/or ejected fromthe syringe device, for example, through a needle. In some embodiments,the advancing can be configured to deliver 0.3 mg or 0.15 mg of the atleast one drug to a user and/or patient. Other amounts of drug can bedelivered in other embodiments.

In some embodiments, the actuator and the spacer may be configured to besecured around the plunger rod and provide the predetermined distancebetween a start point and an end point on the spacer.

Also described herein are methods of making and/or assembling thesyringe devices.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a syringe device as describedherein.

FIG. 2 is an exploded view of the syringe device of FIG. 1.

FIG. 3A illustrates a cross-sectional view of the syringe of FIG. 1 witha first amount of drug filled in the syringe. FIG. 3B illustrates across-sectional view of the syringe of FIG. 1 with a second lesseramount of drug filled in the syringe whereby the actuator 222 andplunger rod 218 have been adjust accordingly. FIG. 3C illustratesanother cross-sectional view of the syringe of FIG. 1.

FIG. 4 illustrates a non-limiting assembly method for the syringedevices as described herein.

FIG. 5A illustrates a side view of a case for the syringe devicesdescribed herein in an open configuration. FIG. 5B illustrates a topview of a case for the syringe devices described herein in an openconfiguration without a syringe device. FIG. 5C illustrates a top viewof a case for the syringe devices described herein in an openconfiguration including a syringe device loaded therein.

FIG. 6 illustrated a case of FIGS. 5A-C in a closed configuration.

FIG. 7 illustrates two cases coupled together to form a single unit.

FIG. 8 illustrates a non-limiting method of using the herein describedsyringe devices.

DETAILED DESCRIPTION

Described herein generally are syringe devices that allow accuratedosing of a drug(s), even in situations that require immediate andsometimes rushed responses. In some embodiments, these situations can beemergency situations where time is of the essence. The syringe devicesand/or any accompanying packaging or casing can be sized so as to besmall enough to be portable. In some embodiments, small size can allowend users to more easily carry the syringe devices and have themavailable in an emergency situation.

The syringe devices described herein can allow for current manufacturingtolerances without affecting delivered volume accuracy as will bedescribed herein. A controlled tolerance loop can be used for a deliverystroke in combination with an adjustable plunger rod at the point ofsecondary packaging. In other words, in some embodiments, volumedelivery accuracy does not change if more or less drug is delivered in asyringe prior to assembly of the syringe device.

Further, features of the syringe devices can prevent outward movement ofa plunger rod/stopper under all conditions by means of a mechanicalstop. A mechanical stop can prevent outward movement that can introduceair into a needle and/or a syringe that can prevent introduction of adrug during an emergency situation. The syringe devices can also includea removable locking mechanism. The locking mechanism can be removedprior to use. This removable locking mechanism can prevent inwardmovement of the plunger rod/stopper up to the point of use.

The syringe devices can also provide tactile feedback to a user at theend of a stroke. This tactile feedback can be useful to inform the userthat a dose has been delivered.

Further, the syringe devices can include a locking feature that locksthe plunger rod down at the stroke end to assure gas bubbledecompression and accurate delivered volume. In some embodiments, a gasbubble is not included and no gas bubble compression exists at the endof a plunger stroke.

The syringe devices can encase a drug filled syringe such that an enduser cannot unscrew or over screw the plunger rod from the stopper andchange the travel stroke and thus delivered volume. In some embodiments,a user would have to physically break open the syringe device in orderto alter drug delivery.

A syringe device can be as illustrated in FIG. 1. FIG. 2 illustrates across-section thereof and FIGS. 3A-C illustrate various cross-sectionsthereof. Syringe device 100 can include a needle 102, a needle guard104, an encasement 106, and a plunger assembly 108. Encasement 106 andplunger assembly 108 can include many features that will be described inmore detail herein.

Encasement 106 can include one or more labels that provide informationabout the drug or drugs being delivered via syringe device 100. Asillustrated in FIG. 1, label 110 can cover substantially an entiresurface of encasement 106. However, in other embodiments, label 110 maynot cover an entire surface of encasement 106 or multiple labels can beused instead of one large label. In fact, in some embodiments, anynumber of labels of any shapes can be used to label the product asneeded.

Encasement 106 can include any number of flanges. Upper flanges canprovide counter balance locations to apply force during injection.Encasement 106 includes a first upper flange 112 on first side 114 andsecond upper flange 116 on second side 118. Encasement 106 can, in otherembodiments, include an upper flange that wraps around the entireperimeter or a substantial portion of perimeter of encasement 106.However, in the embodiment illustrated in FIG. 1, first upper flange 112and second upper flange 116 are not located on top surface 120 andbottom surface 122 in order to reduce the size of syringe device 100.

Encasement 106 can also include a first lower flange 124 on first side114 and second lower flange 126 on second side 118. Again, encasement106 can, in other embodiments, include a lower flange that wraps aroundthe entire perimeter or a substantial portion of perimeter of encasement106. However, in the embodiment illustrated in FIG. 1, first lowerflange 124 and second lower flange 126 are not located on top surface120 and bottom surface 122 in order to reduce the size of syringe device100.

In one embodiment, first lower flange 124 and second lower flange 126create a bottom surface 128. This bottom surface 128 and first lowerflange 124 and second lower flange 126 can aid with needle insertion byproviding a push point. Further, bottom surface 128 with a large surfacearea provided by the flanges can promote correct orientation withrespect to the skin for a maximum needle penetration depth.

One or more areas or portions on the face of encasement 106 can includegripping surfaces. Gripping surfaces can include those with textures,perforations, holes, or any other structures that promote grip ofsyringe device 100. In one embodiment, a gripping surface can behorizontal lines of raised surface. In some embodiments, a grippingsurface can be molded into an encasement, and in other embodiments, agripping surface can be coated in a surface with a high degree offriction, such as rubber. Gripping surfaces or gripping areas canpromote easy grasping of syringe device 100 and promote many differentsyringe holding styles. In one embodiment, a first grip area 130 canexist between first upper flange 112 and first lower flange 124 and asecond grip area 132 can exist between second upper flange 116 andsecond lower flange 126.

Encasement 106 can also include one or more indicia of drugeffectiveness. Indicia can include temperature color change labels thatindicate whether the syringe has been subjected to suboptimaltemperatures, one or more windows that allow a user to view the drugwithin a syringe located within encasement 106, and/or a seal that canbe broken prior to use to alert a user whether the syringe hadpreviously been tampered with. In some embodiments, encasement 106 hasone or more windows through top surface 120, bottom surface 122, orboth. In one embodiment, encasement 106 includes a first window 134 ontop surface 120 and a second window 136 on bottom surface 122. Firstwindow 134 and second window 136 can allow a user to view the drughoused within encasement 106 to see, for example, if a clear solutionmay be cloudy and hence expired.

An exploded view of syringe device 100 is illustrated in FIG. 2. Withinencasement 106 resides several of the syringe device's components.Loaded from distal end 202 of encasement 106 is a syringe stop ring 204that allows a spring 206 to rest within. Syringe stop ring 204 includesa hole 208 through its body through which a needle 102 and syringe bodyis inserted through. Spring 206 can rest between syringe stop ring 204and flange 210 of syringe 212. This arrangement is illustrated incross-sectional FIG. 3. In some embodiments, syringe flange 210 can beheld against spacer 220 by spring 206. If during force of actuation,there is a separation between spacer 220 and syringe flange 210, spring206 can close this separation after user applied force is removed.

Syringe 212 can include an internal volume 214 that can be filled withone or more drugs. Drugs can be extruded and/or ejected from needle 102by applying force to stopper 216 by plunger rod 218. Plunger rod 218 cancome bonded to stopper 216 or can be screwed into or otherwise attachedto stopper using any means known in the art.

Plunger rod 218 is part of plunger assembly 108. Plunger assemblyincludes the plunger rod 218, a spacer 220, actuator 222, and top 224.Plunger rod 218 can include multiple protrusions 226 that can interactwith channels 228 within inner surface of actuator 222. Protrusions 226can lock actuator 222 to plunger rod 218.

Spacer 220 is used as a top stop 230 and a bottom stop 232 for actuatorring 234. Top and bottom stops control the amount of stopper travelthrough syringe 212 and hence the precise amount of drug extruded and/orejected from needle 102. Distance 236 can be defined between top stop230 and bottom stop 232. Distance 236 can be about 1 mm, about 2 mm,about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm,about 9 mm, about 10 mm, about 12 mm, about 14 mm, about 16 mm, about 18mm, about 20 mm, between about 1 mm and about 20 mm, between about 1 mmand about 10 mm, or between about 5 mm and about 10 mm.

In some embodiments, distance 236 can be changed, for example reduced,by increasing the thickness of actuator ring 234. Likewise, distance 236can be increased by reducing the thickness of actuator ring 234. Byincreasing the thickness of an actuator ring, the amount of distancetraveled between top stop 230 and bottom stop 232 can be reducedresulting in less volume of drug being extruded and/or ejected fromneedle 102. Such reduced travel distances can be used with smallerpatients such as children that require less drug to treat a particularsymptom or illness.

In some embodiments, distance 236 can be changed by decreasing thedistance between top stop 230 and bottom stop 232 without changing thethickness of actuator ring 234. By adjusting, e.g., increasing ordecreasing, the distance between top stop 230 and bottom stop 232, theamount of distance traveled between top stop 230 and bottom stop 232 canbe changed resulting in more or less volume of drug being extruded fromneedle 102.

In embodiments, distance 236 can be changed by combinations of adjustingthe thickness of actuator ring 234 and adjusting the distance betweentop stop 230 and bottom stop 232.

Actuator 222 can be adjusted relative to plunger rod 218 based onfilling variability. FIGS. 3A and 3B illustrate this. In other words,regardless of the volume of drug in a particular syringe (and hence alocation of stopper 216 relative to flange 210), actuator 222 andstopper 220 can be attached to plunger rod 218 and provide an accuratevolume delivery of drug without changing manufacturing processes.

In one embodiment, if a syringe is provided with too much drug volume,the actuator and the spacer can be attached around the plunger rod suchthat protrusions 226 are at a higher location in channels 228. In suchan embodiment, the ultimate delivered volume would be the same as if thesyringe was provided with less drug volume.

This changeability of plunger assembly can allow variability in drugfill volume without having to change manufacturing processes toaccommodate different and/or inaccurate fills. The changeability allowsfor a particular volume of drug to be extruded and/or ejected fromneedle 102 regardless of the actual drug fill volume in the syringe.

In some embodiments, a snap is located at bottom stop 232 to lockplunger rod 218 down at the end of an injection stroke. This lockprevents attempted multiple uses of a syringe. In essence, the lockallows a syringe to be a single use, disposable syringe.

Top 224 includes a hole through it to allow the assembled plunger rod218, spacer 220 and actuator 222 to protrude at least partially. Top 224includes at least one tooth, such as first tooth 238 and second tooth240 to snap into portions of encasement 106. After top 224 is lockedinto encasement 106, it acts to lock spacer 220 into place by wedgingspacer 220 between top 224 and syringe flange 210.

In some embodiments, spacer 220, actuator 222, and top 224 can be keyedto encasement 106 to prevent rotation of the components once assembled.

In some embodiments, syringe device 100 can include a needle guard 242.Needle guard 242 can be manually deployed. Needle guard 242 can includeat least one hole 244 that can align with a window on encasement 106when the needle guard has not been manually deployed. Needle guard 242can be deployed to aid in sharps injury prevention after use of syringedevice 100.

Needle guard 242 can be manually deployed by applying pressure to andpulling on one or more tabs 246 away from proximal end 248 of encasement106. Once fully deployed, needle guard 242 can lock into placepreventing needle 102 from being used further or accidentally lancing ahuman handling the used syringe.

Actuator 222 can further include a force application surface 250 at itsdistal end. Force application surface 250 can be a concave surfacepromoting user comfort during actuation of the syringe devices. Further,in some embodiments, force application surface 250 can be textured toaid in user feeling when using the syringe devices.

As further illustrated in FIG. 3, internal volume 214 includes a liquiddrug 252. Existing between liquid drug 252 and stopper 216 can be a gasbubble 254. Gas bubble 254 can be virtually any gas that can occupy thespace required between the liquid drug and the stopper. In someembodiments, the gas can be an inert gas such as, but not limited toargon, nitrogen, helium, and the like. In one embodiment, the gas bubbleis nitrogen. In some embodiments, the devices described herein do notinclude a gas bubble. In other embodiments, the gas bubble is not neededas the end of a plunger stroke may not deplete the volume of liquid inthe syringe.

Drugs housed in syringe 212 can include any compound or active agenthaving a therapeutic effect in an animal. Animals can be mammals whichcan include humans, equines, canines, felines, bovines, and the like. Inone embodiment, an animal can be a human. Non-limiting drugs can includean adrenergic receptor agonist or antagonist, anti-proliferative,estrogen, chaperone inhibitor, protease inhibitor, protein-tyrosinekinase inhibitor, peroxisome proliferator-activated receptor gammaligand (PPARγ), epidermal growth factor inhibitor, proteasome inhibitor,anti-inflammatory, anti-sense nucleotide, transforming nucleic acid,anti-proliferative compound, cytostatic compound, toxic compound,chemotherapeutic agent, analgesic, protease inhibitor, statin, nucleicacid, polypeptide, growth factor, delivery vector, anti-diabetic agent,secretagogue, vitamin, vaccine, steroid, narcotic, hormone, biologicalresponse modifier, antibiotic, antiviral agent, anesthetic, anorexic,antiarthritic, antiasthmatic, anticonvulsant, antidepressant, antigen,antihistamine, antinauseant, antineoplastic, antipruritic,antipsychotic, antipyretic, antispasmodic, calcium channel blocker,beta-blocker, beta-agonist, antiarrythmic, antihypertensive, diuretic,vasodilator, stimulant, decongestant, immunosuppressive, musclerelaxant, psychostimulant, sedative, tranquilizer, or a combinationthereof.

In some embodiments, salts, prodrugs, derivatives and/or analogues ofthe herein described drugs can be provided alone or in combination.

In some embodiments, drug(s) included in the herein described syringescan be used to treat severe allergic reactions (anaphylaxis). Thedrug(s) included in the herein described syringes can be used to treatsymptoms such as difficulty breathing, shortness of breath, tightness ofthroat, fast heartbeat, weak pulse, dizziness, passing out, itching,swelling, itching in the throat, swelling in the throat, vomiting,diarrhea, cramps, or combinations thereof. In some embodiments, thedrug(s) included in the herein described syringes can be used to treatcombinations of the above symptoms in an emergency situation. In stillother embodiments, the drug(s) included in the herein described syringescan be used to treat other symptoms and/or conditions in an emergencysituation. For example, in some embodiments, drugs can be used to treatmedical conditions such as hypoglycemia.

In one embodiment, the drug is epinephrine, salts thereof, derivativesthereof, and/or prodrugs thereof. Epinephrine, salts thereof,derivatives thereof, and/or prodrugs thereof can be present at aconcentration of about 0.01 mg/mL, about 0.025 mg/mL, about 0.05 mg/mL,about 0.075 mg/mL, about 0.1 mg/mL, about 0.2 mg/mL, about 0.3 mg/mL,about 0.4 mg/mL, about 0.5 mg/mL, about 0.6 mg/mL, about 0.7 mg/mL,about 0.8 mg/mL, about 0.9 mg/mL, about 1 mg/mL, about 2 mg/mL, about 3mg/mL, about 4 mg/mL, about 5 mg/mL, about 6 mg/mL, about 7 mg/mL, about8 mg/mL, about 9 mg/mL, about 10 mg/mL, between about 0.01 mg/mL andabout 10 mg/mL, between about 0.1 mg/mL and about 10 mg/mL, at leastabout 0.01 mg/mL, at least about 0.05 mg/mL, or at least about 0.1mg/mL. In other embodiments, epinephrine, salts thereof, derivativesthereof, and/or prodrugs thereof can be included in syringes describedherein to deliver about 0.001 mg, about 0.025 mg, about 0.05 mg, about0.075 mg, about 0.1 mg, about 0.15 mg, about 0.2 mg, about 0.25 mg,about 0.3 mg, about 0.35 mg, about 0.4 mg, about 0.45 mg, about 0.5 mg,about 0.55 mg, about 0.6 mg, about 0.65 mg, about 0.7 mg, about 0.75 mg,about 0.8 mg, about 0.85 mg, about 0.9 mg, about 0.95 mg, about 1 mg,between about 0.001 mg and about 0.5 mg, between about 0.1 mg and about1 mg, at least about 0.001 mg, at least about 0.01 mg, at least about0.1 mg, at least about 0.2 mg, or at least about 0.3 mg of epinephrinein a single injectable dose even if more than that amount is present inthe syringe prior to assembly of a syringe device.

Other drugs described herein can be provided in similar concentrations.In one embodiment, glucagon can be provided as the drug and can bepresent in similar concentrations.

In one embodiment, epinephrine, salts thereof, derivatives thereof,and/or prodrugs thereof can be in a formulation with a carrier. Theformulation can include epinephrine, a salt thereof, derivativesthereof, or prodrugs thereof, one or more tonicity adjuster(s) such ase.g. sodium chloride or other salts, an acid or base to adjust pH, suchas e.g. hydrochloric acid or sodium hydroxide, and a solvent or carrier.In some embodiments, the formulation can be in an aqueous formulationand can also include an antioxidant. The antioxidant can beNa-metabisulfite or other appropriate antioxidant. In still otherembodiments, formulations can include an excipient(s) such as but notlimited to, a preservative(s), a sorbent(s), a lubricant(s), a vehicle,or the like.

In some embodiment, other drugs described herein can be provided insimilar formulations. In one embodiment, glucagon can be provided insimilar formulations.

In some embodiments, the carrier is aqueous. In one embodiment, thecarrier is water for injection.

The salt included in a formulation can be any salt. In one embodiment,the salt is sodium chloride. In some embodiments, a salt can be includedin a formulation to provide an appropriate tonicity.

The acid used to adjust pH of the formulation can be any acid. In oneembodiment, the acid is hydrochloric acid.

In one embodiment, every 0.3 mL of a formulation can include 0.3 mg ofepinephrine, 1.8 mg of sodium chloride, 0.5 mg of sodium metabisulfite,hydrochloric acid to adjust pH, and water for injection.

In another embodiment, every 0.3 mL of a formulation can include 0.15 mgof epinephrine, 1.8 mg of sodium chloride, 0.3 mg of sodiummetabisulfite, hydrochloric acid to adjust pH, and water for injection.

In some embodiments, the drugs can be filled into the syringes in aparticular amount. That particular amount can be about 0.2 cc, about 0.3cc, about 0.4 cc, about 0.5 cc, about 0.6 cc, about 0.7 cc, about 0.8cc, about 0.9 cc, about 1 cc, about 2 cc, between about 0.7 cc and about0.9 cc, between about 0.1 cc and about 1 cc, between about 0.8 cc andabout 0.9 cc. In one embodiment, the filling volume can be about 0.8 cc.

FIG. 4 illustrates a non-limiting assembly method for the syringedevices as described herein. As a first step 400, a syringe is filledwith a desired drug and if desired appropriately sized gas bubble. Insome embodiments, a bubble is not included and/or is not needed. Aplunger rod is then screwed to the syringe's stopper. In a second step402, a spacer is added around the plunger rod. In a next step 404, theactuator is attached opposite the spacer. A top is then placed on thespacer and actuator to complete the plunger assembly in a fourth step406. A spring and a syringe stop ring are then slide down around thesyringe body until they meet the syringe's flange in a fifth step 408.

Separately, in step 410 a needle guard is added to an empty encasementand retracted into the encasement. Appropriate label(s) are added to theencasement in step 410 as well.

Next, in step 412, the encasement is then slid over the syringe thatincludes the plunger assembly and snapped into place attached to thetop's teeth. Any additional labels can be added to complete the assemblyof the herein described syringe in step 414.

In some embodiments, the syringe devices are single use and/ordisposable. Such single use devices are generally used for a singletreatment and then discarded in an appropriate manner consistent withhealth regulations.

In some embodiments, the contents of syringe devices and devicesthemselves are sterile. Sterile syringe devices can be obtained bysterile filling and device assembly or by sterilizing the syringedevices after assembly. The syringe devices described herein can besterilized using conventional sterilization techniques such as, but notlimited to gamma irradiation techniques.

Syringe devices described herein can be packaged for distribution tousers. Packaging can take on forms that can at least partially encase orcover portions of the syringe devices that may be conducive tointerference. In one embodiment, syringe devices can be fully encased.

An example case for syringe device 100 is illustrated in FIGS. 5A-C, 6,and 7. Case 500 can be opened and closed on a hinge 502 and a lockingmechanism 504. Locking mechanism 504 can allow for a single use ormultiple uses. In one embodiment, locking mechanism 504 can be a hookand catch mechanism.

Case 500 can be shaped to fit a single syringe device. FIG. 5Cillustrates a syringe device 100 loaded in case 500. In one embodiment,case 500 can be configured to be at least as long as syringe device 100from the tip of a needle cover to the top of an actuator finger surfacein a ready to use configuration. In other embodiments, case 500 can beconfigured to hold syringe device 100 in an angled configuration.

Allowing syringe device 100 to sit at angle 506 can allow for case 500to have a wider bottom portion 508 than top portion 510. Because topportion 510 and bottom portion 508 are not the same, a non-linear edge512 is created. A second case 514 as illustrated in FIG. 7 can be spun180 degrees and the non-linear edge of each can be matched up.

Angle 506 shown in FIG. 5B can be about 3 degrees, about 4 degrees,about 5 degrees, about 6 degrees, about 7 degrees, about 8 degrees,about 9 degrees, about 10 degrees, between about 3 degrees and about 8degrees, between about 4 degrees and about 6 degrees, or at least about3 degrees. In one embodiment, angle 506 is about 5 degrees.

In some embodiments, each case can include a fastening nub 516 and areceiving orifice 518 can be included on non-linear edge 512. Receivingorifice can have a key hole configuration allowing for fastening nub 516to be inserted into the larger portion of the key hole and slid andlocked into place. Thus, when case 500 and second case 514 are mated,two sets of fastening nubs and a receiving orifices can be used to holdthe two cases together.

Fitting two cases together can allow a user to carry a single dose of adrug in case of an emergency and have a second dose close at hand incase a second dosage is needed. FIG. 7 illustrates tow cases joinedtogether. Angling the syringe device within a case allows for theoverall length of the case to be reduced. The extra width of a case ismitigated by the ability to join two cases together with an overalljoined width that is less than double the width of a single case. Thus,this joined configuration can meet a need to have multiple dosages witha small physical footprint.

Case 500 (or second case 514) can include one or more labels thatprovide information about the drug or drugs being delivered via anenclosed syringe device. As illustrated in FIGS. 5A-C, 6, and 7, caselabel 520 can cover substantially an entire surface of case 500.However, in other embodiments, case label 520 may cover less than anentire surface of case 500 or multiple labels can be used instead of onelarge label. In fact, in some embodiments, any number of labels of anyshapes can be used to label a case as needed.

Cases can be formed of any appropriate material that can house thedescribed syringes through loading, shipping, regular carrying bypatients, and the like without damage to an enclosed syringe device. Insome embodiments, cases can be formed of a polymeric material such as athermoplastic. In one embodiment, cases can be formed of a polypropylenematerial. Cases can be extruded, blow molded, or the like.

Cases can be textured on portions of their surface in order to allow auser to easily grip a case(s). In one embodiment, cases can be texturedusing MT-11010.

Cases can have identification markers such as an arrow(s) indicatingwhich side of the case is used to open it. In some embodiments, raisedfeatures can be used so that a patient in an emergency situation canopen the case without actually focusing on it. Also, in someembodiments, by including a non-linear edge, tactile opening of the casecan be accomplished knowing that the thicker end of the case is opened.

Further, cases can be color coded to indicate a particular drug. Casescan be color coded to indicate the order of use of the enclosed syringedevice.

An example use of a syringe device as described herein is illustrated inFIG. 8. FIG. 8 is illustrated in the context of the non-limiting drug ofepinephrine and illustrates an instruction insert 800. Insert 800includes a diagram 802 of the syringe device itself, labeling thevarious use parts of the device for a clear illustration for a userduring an emergency situation.

As a first step 804, the user is instructed to sit down and locate theinjection area on the thigh as illustrated in the drawing. Althoughdescribed as using a thigh, other injection sites can be used, such asbut not limited to the arm, stomach, buttocks, abdomen, and the like. Insome embodiments, injections can be made into veins.

As a second step 806, a user is instructed to remove the needle cap withthe syringe device pointing up.

As a third step 808, a user is shown how to properly hold the syringedevice for injection. The user is instructed to inject themselves (oranother person can perform the injection) and put the needle in until itis no longer visible. The plunger (actuator) is pushed until it stopsand clicks. The audible click is an indication to the user that the drughas been fully injected. The user is instructed to leave the needle inthe skin for an additional two seconds to allow proper absorption.Further, the user is told that excess liquid will remain in the syringedevice.

The user is instructed in a forth step 810 to remove the needle andslide the needle guard over the needle. The user then places thatsyringe device back in the case and snaps the case closed.

As a fifth step 812, the user is instructed to massage the location forabout 10 seconds. In other embodiments, longer or shorter massages maybe required, such as but not limited to, about 5 seconds, about 15seconds, about 20 seconds, about 25 seconds, about 30 seconds, betweenabout 5 seconds and about 20 seconds, between about 10 seconds and about20 seconds, at least about 5 seconds, or at least about 10 seconds.

As a sixth step 814, the user is instructed to seek medical help and/orto call an emergency line (e.g., 911). The user is told to inform themedical help that they just received an injection of the drug. The useris further instructed to give the used needle case including the usedsyringe device to the medical workers.

As an optional seventh step 816, the user is told to use the secondsyringe device if needed and is told to get medical help immediately ifa second dose is required.

In some embodiments, the syringe devices described herein can beprovided as systems or kits. These systems and kits can include asyringe device enclosed in a container with instructions for use.

In other embodiments, systems and kits can include two syringe deviceseach enclosed in a separate container each with instructions for use. Instill other embodiments, a system or kit can include two syringe devicefilled containers that are connected as described herein.

In one embodiment, systems and kits can include a syringe device filledwith a therapeutic amount of a drug enclosed in a container withinstructions for use. In other embodiments, systems and kits can includetwo syringe devices each filled with a therapeutic amount of a drug,each enclosed in a separate container, and each including instructionsfor use. In still other embodiments, a system or kit can include twosyringe devices filled with a therapeutic amount of a drug in containersthat are connected as described herein.

In one embodiment, systems and kits can include a syringe device filledwith a therapeutic amount of epinephrine enclosed in a container withinstructions for use. In other embodiments, systems and kits can includetwo syringe devices each filled with a therapeutic amount ofepinephrine, each enclosed in a separate container, and each includinginstructions for use. In still other embodiments, a system or kit caninclude two syringe devices filled with a therapeutic amount ofepinephrine in containers that are connected as described herein.

In one embodiment, systems and kits can include a syringe device filledwith a therapeutic amount of glucagon enclosed in a container withinstructions for use. In other embodiments, systems and kits can includetwo syringe devices each filled with a therapeutic amount of glucagon,each enclosed in a separate container, and each including instructionsfor use. In still other embodiments, a system or kit can include twosyringe devices filled with a therapeutic amount of glucagon incontainers that are connected as described herein.

In some embodiments, a syringe device(s) can be distributed to a patientwithout a drug included within it. The syringe device(s) can be loadedinto cases. These syringe devices can be used as training devices toallow a potential user to understand how the syringe device works sothat in an emergency situation, they will be ready to use an actualsyringe device. In some embodiments, a training device may not include aneedle so that a trainee can partake in all the steps except the mostpainful needle injection portion.

In some embodiments, the syringe devices described herein can prevent auser from unscrewing the plunger rod from the stopper. This preventionability of the presently described syringe devices can disallow a changein travel stroke and hence delivered drug volume of traditionalsyringes. Further, the syringe devices described herein can prevent auser moving the plunger rod and/or stopper thereby affecting thedelivery volume of a drug filled syringe device. Further still, thepresently described syringe devices can prevent a user from pulling outand/or back the stopper/plunger rod thereby altering the deliveredvolume and the purity of the drug.

As discussed, the presently described syringe devices can providetactical feedback to alert a user of a complete drug dose delivery.Typical syringes only allow a tactical feedback when the stopper and/orplunger reach an end stop.

The presently described syringe devices can also prevent a user frommodifying the plunger and/or stopper to alter the amount of preset drugdelivery. The present syringe devices can deliver a preset drug dosagewithout intervention by the user that can alter to amount of drugdelivered.

The presently described syringe devices can prevent suboptimal druginjections by preventing unexpected syringe delivery orientations.Syringes can generally provide optimal delivery of drugs when orientedin a particular angle for injection. The present syringe devices canprovide a surface that can press against the injection site andeffectively hold the syringe devices at a predetermined angle forinjection.

The following represent non-limiting embodiments.

Embodiment 1: A syringe device comprising: a syringe including atherapeutic dose of at least one drug and a stopper; and a plungerassembly including a plunger rod, an actuator, and a spacer, wherein theplunger assembly is configured to move the stopper a predetermineddistance without a user touching the plunger rod or being able toretract the plunger rod.

Embodiment 2: The syringe device of embodiment 1, wherein the plungerassembly is configured to provide substantially identical doses of theat least one drug even if more or less drug is provided in the syringeby moving the stopper a predetermined distance.

Embodiment 3: The syringe device of embodiment 1 or 2, further includingan encasement configured to house the syringe.

Embodiment 4: The syringe device of embodiment 1, 2, or 3, wherein theencasement includes a window configured to allow the user to view the atleast one drug in the syringe.

Embodiment 5: The syringe device of embodiment 1, 2, 3, or 4, whereinthe encasement includes a needle guard configured to allow the user tocover the needle after use.

Embodiment 6: The syringe device of embodiment 1, 2, 3, 4, or 5, whereinthe at least one drug is an adrenergic receptor agonist or antagonist,anti-proliferative, estrogen, chaperone inhibitor, protease inhibitor,protein-tyrosine kinase inhibitor, peroxisome proliferator-activatedreceptor gamma ligand (PPAR└), epidermal growth factor inhibitor,proteasome inhibitor, anti-inflammatory, anti-sense nucleotide,transforming nucleic acid, anti-proliferative compound, cytostaticcompound, toxic compound, chemotherapeutic agent, analgesic, proteaseinhibitor, statin, nucleic acid, polypeptide, growth factor, deliveryvector, anti-diabetic agent, secretagogue, vitamin, vaccine, steroid,narcotic, hormone, biological response modifier, antibiotic, antiviralagent, anesthetic, anorexic, antiarthritic, antiasthmatic,anticonvulsant, antidepressant, antigen, antihistamine, antinauseant,antineoplastic, antipruritic, antipsychotic, antipyretic, antispasmodic,calcium channel blocker, beta-blocker, beta-agonist, antiarrythmic,antihypertensive, diuretic, vasodilator, stimulant, decongestant,immunosuppressive, muscle relaxant, psychostimulant, sedative,tranquilizer, or a combination thereof.

Embodiment 7: The syringe device of embodiment 1, 2, 3, 4, 5, or 6,wherein the at least one drug is epinephrine.

Embodiment 8: The syringe device of embodiment 1, 2, 3, 4, 5, 6, or7,wherein the syringe device is configured to deliver about 0.15 mg orabout 0.3 mg of epinephrine.

Embodiment 9: The syringe device of embodiment 1, 2, 3, 4, 5, or 6,wherein the at least one drug is glucagon.

Embodiment 10: The syringe device of embodiment 1, 2, 3, 4, 5, 6, 7, 8,or 9, wherein the actuator and the spacer are configured to be securedaround the plunger rod.

Embodiment 11: The syringe device of embodiment 1, 2, 3, 4, 5, 6, 7, 8,9, or 10, wherein the actuator includes a finger depression location.

Embodiment 12: The syringe device of embodiment 1, 2, 3, 4, 5, 6, 7, 8,9, 10, or 11 configured for use in an emergency.

Embodiment 13: A method for administering a therapeutic dose of at leastone drug, the method comprising: advancing a stopper through a syringeincluding the therapeutic dose of the at least one drug; wherein thestopper is only advanced a predetermined distance by a plunger assemblyincluding a plunger rod, an actuator, and a spacer, wherein the plungerassembly is configured to move the stopper without a user touching theplunger rod.

Embodiment 14: The method of embodiment 13, wherein the syringe ishoused in an encasement.

Embodiment 15: The method of embodiment 13 or 14, wherein the encasementincludes a window configured to allow the user to view the at least onedrug in the syringe.

Embodiment 16: The method of embodiment 13, 14, or 15, wherein theencasement includes a needle guard configured to allow the user to covera needle after use.

Embodiment 17: The method of embodiment 13, 14, 15, or 16, wherein theadvancing the stopper the predetermined distance is configured todeliver about 0.15 mg or about 0.3 mg of the at least one drug.

Embodiment 18: The method of embodiment 13, 14, 15, 16, or 17, whereinthe at least one drug is an adrenergic receptor agonist or antagonist,anti-proliferative, estrogen, chaperone inhibitor, protease inhibitor,protein-tyrosine kinase inhibitor, peroxisome proliferator-activatedreceptor gamma ligand (PPAR|), epidermal growth factor inhibitor,proteasome inhibitor, anti-inflammatory, anti-sense nucleotide,transforming nucleic acid, anti-proliferative compound, cytostaticcompound, toxic compound, chemotherapeutic agent, analgesic, proteaseinhibitor, statin, nucleic acid, polypeptide, growth factor, deliveryvector, anti-diabetic agent, secretagogue, vitamin, vaccine, steroid,narcotic, hormone, biological response modifier, antibiotic, antiviralagent, anesthetic, anorexic, antiarthritic, antiasthmatic,anticonvulsant, antidepressant, antigen, antihistamine, antinauseant,antineoplastic, antipruritic, antipsychotic, antipyretic, antispasmodic,calcium channel blocker, beta-blocker, beta-agonist, antiarrythmic,antihypertensive, diuretic, vasodilator, stimulant, decongestant,immunosuppressive, muscle relaxant, psychostimulant, sedative,tranquilizer, or a combination thereof.

Embodiment 19: The method of embodiment 13, 14, 15, 16, 17, or 18,wherein the at least one drug is epinephrine or glucagon.

Embodiment 20: The method of embodiment 13, 14, 15, 16, 17, 18, or 19,wherein the actuator and the spacer are configured to be secured aroundthe plunger rod and provide the predetermined distance.

Embodiment 21: The method of embodiment 13, 14, 15, 16, 17, 18, 19, or20, wherein the actuator and the spacer are configured to provide thepredetermined distance between a start point and an end point.

EXAMPLE 1 Emergency Epinephrine Self Injection

A 45 year old female suffers from a peanut allergy. After accidentallyingesting peanut butter, the female begins to suffer from a severeallergic reaction wherein she begins to sweat and struggle breathing.She instantly reaches into her purse and pulls out a kit of twoepinephrine filled syringe devices housed in separate connected cases.She pops open one case and removes the syringe device.

The woman sits down and selects an injection area on her thigh. Sheremoves the needle cap, inserts the needle into her thigh in theselected area, and pushes the plunger until she hears a click. Sheleaves the needle in her thigh for an additional two seconds. She thenremoves the needle from her thigh, slides down the needle cap, placesthe syringe device back in the container, and shuts the container. Thecontainer is now ready to be properly disposed of.

She massages the injection location for about 10 seconds. The womanbreaths slowly and begins to feel her airway opening up. She decides notto take a second dose. She then seeks proper medical attention.

EXAMPLE 2 Emergency Epinephrine Aided Injection

A 12 year old boy suffers from a wasp sting allergy. After being stungby a wasp while playing in the yard, the boy's father finds the boybarely conscious while gasping for air. The father has his wife call 911while he pulls out a kit of two epinephrine filled syringe deviceshoused in separate connected cases. He pops open one case and removesthe syringe device.

The father selects an injection area on the son's thigh. He removes theneedle cap, inserts the needle into the son's thigh in the selectedarea, and pushes the plunger until he hears a click. He leaves theneedle in the son's thigh for an additional two seconds. He then removesthe needle from the son's thigh, slides down the needle cap, places thesyringe device back in the container, and shuts the container.

The father massages the injection location while observing the son'sbreathing. The son's breathing is not improving. The father injects asecond dose from the second syringe device in the kit. The son'sbreathing improves with the second dose. The paramedics arrive a fewminutes later.

EXAMPLE 3 Emergency Glucagon Aided Injection

A wife finds her 35 year old type one diabetic husband unconscious onthe floor. The wife calls 911 while she pulls out a kit of two glucagonfilled syringe devices housed in separate connected cases. She pops openone case and removes the syringe device.

She selects an injection area on the husband's buttocks. She removes theneedle cap, inserts the needle into the husband's buttocks in theselected area, and pushes the plunger until she hears a click. Sheleaves the needle in the husband's buttocks for an additional twoseconds. She then removes the needle from the husband's buttocks, slidesdown the needle cap, places the syringe device back in the container,and shuts the container.

The wife massages the injection location while observing the husband.The husband begins to regain consciousness. The wife decides not toinject the second dose. The paramedics arrive a few minutes later.

Unless otherwise indicated, all numbers expressing quantities ofingredients, properties such as molecular weight, reaction conditions,and so forth used in the specification and claims are to be understoodas being modified in all instances by the term “about.” Accordingly,unless indicated to the contrary, the numerical parameters set forth inthe specification and attached claims are approximations that may varydepending upon the desired properties sought to be obtained by thepresent invention. At the very least, and not as an attempt to limit theapplication of the doctrine of equivalents to the scope of the claims,each numerical parameter should at least be construed in light of thenumber of reported significant digits and by applying ordinary roundingtechniques. Notwithstanding that the numerical ranges and parameterssetting forth the broad scope of the invention are approximations, thenumerical values set forth in the specific examples are reported asprecisely as possible. Any numerical value, however, inherently containscertain errors necessarily resulting from the standard deviation foundin their respective testing measurements.

The terms “a,” “an,” “the” and similar referents used in the context ofdescribing the invention (especially in the context of the followingclaims) are to be construed to cover both the singular and the plural,unless otherwise indicated herein or clearly contradicted by context.Recitation of ranges of values herein is merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range. Unless otherwise indicated herein, eachindividual value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context. The use of any and allexamples, or exemplary language (e.g., “such as”) provided herein isintended merely to better illuminate the invention and does not pose alimitation on the scope of the invention otherwise claimed. No languagein the specification should be construed as indicating any non-claimedelement essential to the practice of the invention.

Groupings of alternative elements or embodiments of the inventiondisclosed herein are not to be construed as limitations. Each groupmember may be referred to and claimed individually or in any combinationwith other members of the group or other elements found herein. It isanticipated that one or more members of a group may be included in, ordeleted from, a group for reasons of convenience and/or patentability.When any such inclusion or deletion occurs, the specification is deemedto contain the group as modified thus fulfilling the written descriptionof all Markush groups used in the appended claims.

Certain embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention. Ofcourse, variations on these described embodiments will become apparentto those of ordinary skill in the art upon reading the foregoingdescription. The inventor expects skilled artisans to employ suchvariations as appropriate, and the inventors intend for the invention tobe practiced otherwise than specifically described herein. Accordingly,this invention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

In closing, it is to be understood that the embodiments of the inventiondisclosed herein are illustrative of the principles of the presentinvention. Other modifications that may be employed are within the scopeof the invention. Thus, by way of example, but not of limitation,alternative configurations of the present invention may be utilized inaccordance with the teachings herein. Accordingly, the present inventionis not limited to that precisely as shown and described.

We claim:
 1. A syringe device comprising: a syringe including atherapeutic dose of at least one drug and a stopper; and a plungerassembly including a plunger rod, an actuator including an actuatorring, and a spacer including a top stop and a bottom stop, wherein theplunger rod is configured to attach to the actuator and direct theactuator ring from the top stop to the bottom stop, wherein the spaceris attached around part of the plunger rod and is opposite the actuator,and wherein the plunger assembly is configured to move the stopper apredetermined distance without a user touching the plunger rod or beingable to retract the plunger rod.
 2. The syringe device of claim 1,wherein the plunger assembly is configured to provide substantiallyidentical doses of the at least one drug even if more or less of the atleast one drug is provided in the syringe by moving the stopper apredetermined distance.
 3. The syringe device of claim 1, furtherincluding: an encasement configured to house the syringe.
 4. The syringedevice of claim 3, wherein the encasement includes a window configuredto allow the user to view the at least one drug in the syringe.
 5. Thesyringe device of claim 1, wherein the therapeutic dose of the at leastone drug is about 0.1 cc to 1 cc.
 6. The syringe device of claim 1,wherein the therapeutic dose of the at least one drug is about 0.5 cc.7. The syringe device of claim 1, wherein the at least one drug is anadrenergic receptor agonist or antagonist, anti-proliferative, estrogen,chaperone inhibitor, protease inhibitor, protein-tyrosine kinaseinhibitor, peroxisome proliferator-activated receptor gamma ligand(PPARγ), epidermal growth factor inhibitor, proteasome inhibitor,anti-inflammatory, anti-sense nucleotide, transforming nucleic acid,anti-proliferative compound, cytostatic compound, toxic compound,chemotherapeutic agent, analgesic, protease inhibitor, statin, nucleicacid, polypeptide, growth factor, delivery vector, anti-diabetic agent,secretagogue, vitamin, vaccine, steroid, narcotic, hormone, biologicalresponse modifier, antibiotic, antiviral agent, anesthetic, anorexic,antiarthritic, antiasthmatic, anticonvulsant, antidepressant, antigen,antihistamine, antinauseant, antineoplastic, antipruritic,antipsychotic, antipyretic, antispasmodic, calcium channel blocker,beta-blocker, beta-agonist, antiarrythmic, antihypertensive, diuretic,vasodilator, stimulant, decongestant, immunosuppressive, musclerelaxant, psychostimulant, sedative, tranquilizer, or a combinationthereof.
 8. The syringe device of claim 1, wherein the at least one drugis epinephrine or a salt thereof.
 9. The syringe device of claim 8,wherein the syringe device is configured to deliver about 0.15 mg orabout 0.3 mg of epinephrine or a salt thereof.
 10. The syringe device ofclaim 1, wherein the at least one drug is glucagon.
 11. The syringedevice of claim 1, wherein the actuator and the spacer are configured tobe secured around the plunger rod.
 12. The syringe device of claim 1,wherein the actuator includes a finger depression location.
 13. Thesyringe device of claim 1 configured for use in an emergency.
 14. Amethod for administering a therapeutic dose of at least one drug, themethod comprising: advancing a stopper through a syringe including thetherapeutic dose of the at least one drug; wherein the stopper is onlyadvanced a predetermined distance by a plunger assembly including aplunger rod, an actuator including an actuator ring, and a spacerincluding a top stop and a bottom stop, wherein the plunger rod isconfigured to attach to the actuator and direct the actuator ring fromthe top stop to the bottom stop, wherein the spacer is attached aroundpart of the plunger rod and is opposite the actuator, and wherein theplunger assembly is configured to move the stopper without a usertouching the plunger rod.
 15. The method of claim 14, wherein thesyringe is housed in an encasement.
 16. The method of claim 15, whereinthe encasement includes a window configured to allow the user to viewthe at least one drug in the syringe.
 17. The method of claim 14,wherein the therapeutic dose of at least one drug is about 0.1 cc to 1cc.
 18. The method of claim 14, wherein the therapeutic dose of at leastone drug is about 0.5 cc.
 19. The method of claim 14, wherein advancingthe stopper the predetermined distance is configured to deliver about0.15 mg or about 0.3 mg of the at least one drug.
 20. The method ofclaim 14, wherein the at least one drug is an adrenergic receptoragonist or antagonist, anti-proliferative, estrogen, chaperoneinhibitor, protease inhibitor, protein-tyrosine kinase inhibitor,peroxisome proliferator-activated receptor gamma ligand (PPARy),epidermal growth factor inhibitor, proteasome inhibitor,anti-inflammatory, anti-sense nucleotide, transforming nucleic acid,anti-proliferative compound, cytostatic compound, toxic compound,chemotherapeutic agent, analgesic, protease inhibitor, statin, nucleicacid, polypeptide, growth factor, delivery vector, anti-diabetic agent,secretagogue, vitamin, vaccine, steroid, narcotic, hormone, biologicalresponse modifier, antibiotic, antiviral agent, anesthetic, anorexic,antiarthritic, antiasthmatic, anticonvulsant, antidepressant, antigen,antihistamine, antinauseant, antineoplastic, antipruritic,antipsychotic, antipyretic, antispasmodic, calcium channel blocker,beta-blocker, beta-agonist, antiarrythmic, antihypertensive, diuretic,vasodilator, stimulant, decongestant, immunosuppressive, musclerelaxant, psychostimulant, sedative, tranquilizer, or a combinationthereof.
 21. The method of claim 20, wherein the at least one drug isepinephrine or a salt thereof or glucagon or a salt thereof.
 22. Themethod of claim 14, wherein the actuator and the spacer are configuredto be secured around the plunger rod and provide the predetermineddistance.
 23. The method of claim 14, wherein the actuator and thespacer are configured to provide the predetermined distance between astart point and an end point.